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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02564523
Other study ID # CR107249
Secondary ID VAC52150EBL20022
Status Completed
Phase Phase 2
First received
Last updated
Start date November 6, 2015
Est. completion date February 12, 2019

Study information

Verified date February 2022
Source Janssen Vaccines & Prevention B.V.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of three heterologous prime-boost regimens for Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo. The study will include healthy adults and elderly participants, HIV infected participants and healthy children in 2 age strata.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Ad26.ZEBOV
One 0.5 mL intramuscular (IM) injection of (5x10*10 viral particles)
MVA-BN-Filo
One 0.5 mL IM injection of (1x10*8 infectious units)
Placebo
One 0.5 mL IM injection of 0.9% saline

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Janssen Vaccines & Prevention B.V. Centre Muraz, EBOVAC2 Consortium, Institut National de la Santé Et de la Recherche Médicale, France

Countries where clinical trial is conducted

Burkina Faso,  Côte D'Ivoire,  Kenya,  Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Events (Day 29) An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Up to 28 days post-dose 1 (Day 29)
Primary Number of Participants With Adverse Events (AEs) (28-Day Interval) An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Up to 28 days post-dose 2 (Day 57 for Cohorts 1, 2a, 2b and 3 [28-Day Interval])
Primary Number of Participants With Adverse Events (56-day Interval) An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Up 28 days post-dose 2 (Day 85 for Cohorts 1, 2a, 2b and 3 [56-Day Interval])
Primary Number of Participants With Adverse Events (84-day Interval) An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Up to 28 days post-dose 2 (Day 113 for Cohort 1 [84-Day Interval])
Primary Number of Participants With Adverse Events Post-dose 3 (Day 393) An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Up 28 days post-dose 3 (Day 393)
Primary Number of Participants With Serious Adverse Events A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Up to 3 years and 3 months
Primary Number of Participants With Immediate Reportable Events (IREs) The following neuroinflammatory disorders were considered immediate reportable events which had to be reported to the sponsor within 24 hours of becoming aware of the event. Neuroinflammatory disorders included: cranial nerve disorders including paralyses/paresis (example: bell's palsy), optic neuritis, multiple sclerosis, transverse myelitis, guillain-barre syndrome including miller fisher syndrome, bickerstaff's encephalitis and other variants, acute disseminated encephalomyelitis, including site-specific variants (example: non-infectious encephalitis, encephalomyelitis, myelitis, myeloradiculomyelitis), myasthenia gravis and lambert-eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, including chronic inflammatory, demyelinating polyneuropathy, multifocal motor neuropathy, and polyneuropathies associated with monoclonal gammopathy, narcolepsy, isolated paresthesia of more than 7 days duration. Up to 3 years and 3 months
Primary Number of Participants With Solicited Local Adverse Events (Day 8) An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site. 7 days post-dose 1 (Day 8)
Primary Number of Participants With Solicited Local Adverse Events (28-day Interval) An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site. Up to 7 days post-dose 2 (Day 36 for Cohort 1, 2a, 2b and 3 [28-Day Interval])
Primary Number of Participants With Solicited Local Adverse Events Post-dose 2 (56-day Interval) An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site. Up to 7 days post-dose 2 (Day 64 for Cohort 1, 2a, 2b and 3 [56-Day Interval])
Primary Number of Participants With Solicited Local Adverse Events (84-day Interval) An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site. Up to 7 days post-dose 2 (Day 92 for Cohort 1 [84-Day Interval])
Primary Number of Participants With Solicited Local Adverse Events (Day 372) An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site. Up 7 days post-dose 3 (Day 372)
Primary Number of Participants With Solicited Systemic Adverse Events (Day 8) An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills. Up to 7 days post-dose 1 (Day 8)
Primary Number of Participants With Solicited Systemic Adverse Events (28-Day Interval) An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills. Up to 7 days post-dose 2 (Day 36 for Cohorts 1, 2a, 2b and 3 [28-Day Interval])
Primary Number of Participants With Solicited Systemic Adverse Events (56-Day Interval) An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills. Up 7 days post-dose 2 (Day 64 for Cohort 1, 2a, 2b and 3 [56-Day Interval])
Primary Number of Participants With Solicited Systemic Adverse Events (84-Day Interval) An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills. Up 7 days post-dose 2 (Day 92 for Cohort 1 [84-Day Interval])
Primary Number of Participants With Solicited Systemic Adverse Events (Day 372) An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills. Up to 7 days post-dose 3 (Day 372)
Secondary Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Filovirus Animal Non-Clinical Group (FANG) Enzyme-linked Immunosorbent Assay GMCs of antibodies binding to EBOV GP using FANG ELISA were reported and were measured in ELISA unit per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using FANG ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the lower limit of quantification (LLOQ) (36.11 ELISA units/mL). 21-days post-dose 2 (Day 50 for Cohorts 1, 2a, 2b, 3 [28-day interval] , Day 78 for Cohort 1, 2a, 2b, 3 [56-day interval] and Day 106 Cohort 1 [84-day interval]
Secondary Number of Participants With Serious Adverse Events Post-dose 3 A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Up 28 days post-dose 3 (Day 393)
See also
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Completed NCT02283099 - Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of a Ebola Virus Vaccine (rVSVΔG-ZEBOV-GP) Phase 1
Terminated NCT02661464 - Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo Phase 3
Recruiting NCT02967003 - Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo Phase 3
Completed NCT02354404 - Clinical Trial of Ebola Vaccines cAd3-EBO, cAd3-EBOZ and MVA-EbolaZ in Healthy Adults in Uganda Phase 1
Completed NCT02342171 - Emergency Evaluation of Convalescent Plasma for Ebola Viral Disease (EVD) in Guinea Phase 2/Phase 3
Completed NCT02598388 - Safety, Tolerability and Immunogenicity Study of 2-dose Heterologous Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo Phase 2
Completed NCT02564575 - Evaluating the Safety of and Immune Response to a Human Parainfluenza Virus Type 3 Ebola Virus Vaccine (HPIV3-EbovZ GP) in Healthy Adults Phase 1
Completed NCT02378753 - STRIVE (Sierra Leone Trial to Introduce a Vaccine Against Ebola) Phase 2/Phase 3
Available NCT05067166 - Open-Label Expanded Access for Ebola-Infected Patients to Receive Human mAb Ansuvimab as Therapeutic or for HR PEP